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A kind of method for separating and measuring canagliflozin and related substances

A technology related to substances and organic phases, applied in the direction of material separation, measuring devices, and analyzing materials, etc., to achieve the effects of high theoretical plate number, small baseline noise, and good specificity

Active Publication Date: 2021-03-30
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, there is no report on the determination method of related substances of canagliflozin and its composition. In order to ensure the controllable quality of canagliflozin bulk drug and its pharmaceutical composition, to ensure its effectiveness and safety, a method is urgently needed. An effective detection method that can separate and determine canagliflozin and its related substances

Method used

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  • A kind of method for separating and measuring canagliflozin and related substances
  • A kind of method for separating and measuring canagliflozin and related substances
  • A kind of method for separating and measuring canagliflozin and related substances

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Instruments and Conditions

[0052] High performance liquid chromatography: Agilent 1260;

[0053] Chromatographic column: a chromatographic column filled with butylsilane bonded silica gel (Inertsil-C4, 4.6×250mm, 5µm);

[0054] Mobile phase A: aqueous phosphoric acid solution, take purified water, adjust the pH value to 3.5 with phosphoric acid, mobile phase B: organic phase acetonitrile;

[0055] Elute according to the gradient elution table (see Table 1) (after 50 min, it is the stage of flushing the column to balance the system).

[0056]

[0057] Injection volume: 20μl;

[0058] Column temperature: 25°C;

[0059] Detection wavelength: 210nm.

[0060] Experimental procedure

[0061] Take about 25 mg of canagliflozin raw material, accurately weigh it, put it in a 50 ml volumetric flask, add solvent 70% acetonitrile solution to dissolve and dilute to the mark, shake well, and use it as the test solution. Get solvent and need testing solution, carry out HPLC ...

Embodiment 2

[0063] Instruments and Conditions

[0064] High performance liquid chromatography: Agilent 1260;

[0065] Chromatographic column: a chromatographic column filled with butylsilane bonded silica gel (Inertsil-C4, 4.6×250mm, 5µm);

[0066] Mobile phase A: phosphoric acid solution, take purified water, adjust the pH value to 3.5 with phosphoric acid, mobile phase B: acetonitrile;

[0067] Elute according to the gradient elution table (see Table 2) (after 50 min, it is the stage of flushing the column to balance the system).

[0068]

[0069] Injection volume: 20μl;

[0070] Column temperature: 25°C.

[0071] Experimental procedure

[0072] Take about 25 mg of the crude drug of canagliflozin, accurately weigh it, put it in a 50 ml volumetric flask, add solvent 70% acetonitrile solution to dissolve and dilute to the mark, shake well, and use it as the test solution. Get need testing solution, carry out HPLC analysis under above-mentioned chromatographic condition, with 210nm...

Embodiment 3

[0074] Instruments and Conditions

[0075] High performance liquid chromatography: Agilent 1260;

[0076] Chromatographic column: a chromatographic column filled with butylsilane bonded silica gel (Inertsil-C4, 4.6×250mm, 5µm);

[0077] One set of mobile phase A: phosphoric acid solution, take purified water, use phosphoric acid to adjust the pH value to 2.0, another set of mobile phase A: phosphoric acid solution, take purified water, use phosphoric acid to adjust the pH value to 6.0, mobile phase B: acetonitrile; The mobile phase A of the group was combined with the mobile phase B respectively according to the gradient elution table (see Table 3) and eluted once (after 50 minutes, it was the stage of flushing the column to balance the system).

[0078]

[0079] Injection volume: 20μl;

[0080] Column temperature: 25°C.

[0081] Experimental procedure

[0082] Take about 25 mg of the crude drug of canagliflozin, accurately weigh it, put it in a 50 ml volumetric flask, ...

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Abstract

The invention discloses a method for separating and testing canagliflozin and matter related to the same. According to the method, a high performance liquid chromatography is adopted, butyl silane bonded silica filler serves as a chromatographic column, a phosphoric acid solution and acetonitrile form a flow phase, and gradient elution is conducted. By means of the method, the canagliflozin and matter related to the same can be well separated, the reproducibility of detection is good, sensitivity is good, specificity is high, operation is simple and convenient, and it is beneficial to control the quality and medication safety of the canagliflozin.

Description

technical field [0001] The invention belongs to the field of drug analysis methods, and in particular relates to a method for separating and measuring the hypoglycemic drug canagliflozin and its related substances by using high performance liquid chromatography. Background technique [0002] Canagliflozin is a selective sodium-glucose cotransporter (SGLT) inhibitor for the treatment of type 2 diabetes in adults. Canagliflozin restricts the reabsorption of most glucose in the body by selectively inhibiting the sodium-glucose co-transporter, and promotes a large amount of glucose to be excreted from the urine to control blood sugar levels. Due to the increase of urine sugar, the calorie in the body is reduced, so it has obvious weight loss effect. Systolic blood pressure decreased slightly due to increased sodium excretion, but serum sodium did not change significantly. [0003] The chemical structural formula of canagliflozin is as follows: [0004] [0005] Its chemica...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 陈皓刘泽荣张道林唐远富付晓泰
Owner CHONGQING PHARMA RES INST
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